Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial

Abstract Objective To assess the effects of an additional programme of physiotherapy in adults with a first-time traumatic shoulder dislocation compared with single session of advice, supporting materials, and option to self-refer to physiotherapy. Design Pragmatic, multicentre, randomised controlled trial (ARTISAN). Setting and participants Trauma research teams at 41 UK NHS Trust sites screened adults with a first time traumatic anterior shoulder dislocation confirmed radiologically, being managed non-operatively. People were excluded if they presented with both shoulders dislocated, had a neurovascular complication, or were considered for surgical management. Interventions One session of advice, supporting materials, and option to self-refer to physiotherapy (n=240) was assessed against the same advice and supporting materials and an additional programme of physiotherapy (n=242). Analyses were on an intention-to-treat basis with secondary per protocol analyses. Main outcome measures The primary outcome was the Oxford shoulder instability score (a single composite measure of shoulder function), measured six months after treatment allocation. Secondary outcomes included the QuickDASH, EQ-5D-5L, and complications. Results 482 participants were recruited from 40 sites in the UK. 354 (73%) participants completed the primary outcome score (n=180 allocated to advice only, n=174 allocated to advice and physiotherapy). Participants were mostly male (66%), with a mean age of 45 years. No significant difference was noted between advice compared with advice and a programme of physiotherapy at six months for the primary intention-to-treat adjusted analysis (between group difference favouring physiotherapy 1.5 (95% confidence interval −0.3 to 3.5)) or at earlier three month and six week timepoints. Complication profiles were similar across the two groups (P>0.05). Conclusions An additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy. Trial registration Current Controlled Trials ISRCTN63184243.


Figures
Additional intervention details: Core ARTISAN advice session details  Due to the uncertainty around the appropriateness of the age cut point, a Gaussian mixture model with a support of two was used to identify the best fit of the ages of the randomized participants.The age where the probability of membership in either distribution was equal was at 33 years of age.As this was within 10 years of the randomisation stratum (age of 40), no further sensitivity analyes exploring the effects of age were conducted.Figure 3 shows probability density plots of the participant age.Two distributions were fit, centred at 24 and 56 years old, with the point where probability of membership in both distributions was 50% at 33 years of age

Table 1: Additional intervention details: Core ARTISAN advice session details
Throughout the ARTISAN study, 96 therapists delivered the core ARTISAN session across the 40 study sites.The median number of therapists at each site was 2 and ranged from 1 to 7. The minimum number of participants randomized by each therapist ranged from 1 to 21 randomisations; and of the 96 therapists, only 42 (44%) randomized more than three participants At the interim analysis point, an estimate of the therapist effect by calculating the intra-cluster correlation coefficient (ICC) using the 3-month follow-up data was estimated using a multi-level model (MLM).A χ 2 test comparing the likelihood of the full model against the model without the physiotherapist effect was also conducted.The ICC was estimated to be 0.0201 with 95% CI 0 -0.601 (Participants n = 138; physiotherapists N= 67).The addition of physical therapy effects did not improve the model (χ 2 = -2.27e-13,df = 1, P = 1).
The analysis was repeated using the six-month follow up data at the end of the study to check if the interim analysis was correct.Again, 12 sites had a single physiotherapist performing the randomisation of the participants into the ARTISAN study, and many physiotherapists still did not randomise more than three participants.
Repeating the interim analysis using the final 6-month up data showed that the physiotherapist effect was small and statistically insignificant.The model was adjusted for if the dominant arm was injured, age group and physiotherapist, but did not include the allocation group (354 participants and 80 physiotherapists).An ICC value of 0.026 was observed with 95% confidence interval of 0 -0.106, was observed.Again, comparing the models with and without the physical therapy effects had χ 2 = 0.638 and p-value = 0.424.Again, this showed that including physical therapy effects did not improve the model fit.
Details of the core (pre-randomisation) ARTISAN advice session are given in eTable1.Four hundred and sixty participants were given as per protocol, with 22 participants core ARTISAN session details missing.The mean time taken to deliver the ARTISAN session were similar in both interventions.
Table 1 also contains the self-reported grade of the physiotherapists who delivered the additional physical therapy sessions.(*Note that 22 participant's data were missing).Rotation with a gym ball 1 Internal rotation with a stick 7 Internal rotation with a towel 10 Extension with a stick 2

Glenohumeral control 22
Standing weight drop 16 Lying weight drop 3 Other strength exercise 99 Adv1: floor push ups 22 Wall push ups 40 Gym ball push ups 3 Gym ball weight transfer 5

Sport specific drills 5
Falling press up, waist level 6 Falling press up, standing height 0

Table 3: Post hoc per protocol (additional physical therapy received)
In this scenario, we only consider the intervention to be the receipt or not of additional physical therapy sessions.That is, the comparison of those participants in the advice only group who did not have further physical therapy session with participants in the advice and additional physical therapy group who received at least one further session of physical therapy.
Repeating the primary analysis with these participants yielded a model which did not converge.However, including site as a fixed effect showed no significant differences between the two interventions, and broadly similar model coefficients, as shown in eTable3  The study pre-specified a subgroup analysis to explore if there is evidence of differences in the intervention effects between participants who injured their dominant arm and non-dominant arm.This was explored by adding an interaction term between the allocation group and dominant arm injury term in the ITT model.The results show that there were no significant differences, nor was the model largely altered.The study also pre-specified a subgroup analysis to explore if there is evidence of differences in the intervention effects between the two participant age groups.Again, this was explored by adding an interaction term between the allocation and age groups.
The interaction model for age group showed that older participants who were in the additional physical therapy arm had a small decline in mean function by 0.64 points over those participants allocate to advice only.However, the younger participants mean scores increased by 3.8 points when receiving further physiotherapy compared to advice only.However, this is not a statistically significant or clinically meaningful effect in either case.

Figure 1 :
Figure 1: Diagram of participant pathway for the ARTISAN only group Figure 2: Diagram of physical therapy pathways for the ARTISAN Plus group Figure 3: Age group cut point

Figure 1 :Figure 2 :Figure 3 :
Figure 1: Diagram of participant pathway for the ARTISAN only group

Table 2 :
Additional physical therapy delivered during additional session

Table 3 :
Post hoc per protocol (additional physical therapy received)

Table 5 :
Pre-Specified subgroup: Age group